A recent, extensive clinical trial conducted across India has delivered significant findings regarding the safety of Ashwagandha, a traditional Ayurvedic herb. The study, backed by the Ministry of Ayush, concluded that a standardized Ashwagandha root extract was well-tolerated over a 24-week period, with no reported liver or kidney injury directly attributable to the treatment.
Groundbreaking Safety Evidence for Ashwagandha
The trial involved 1,200 vaccinated adults across seven centers in India. Participants were randomly assigned to receive either 500 mg daily of a standardized aqueous Ashwagandha root extract or a placebo. Researchers meticulously monitored participants for 28 weeks, including 24 weeks of active treatment, assessing liver and kidney function through blood tests. The results, published in Frontiers in Medicine, showed that all blood test parameters remained within normal reference ranges, confirming the extract's safety profile.
Dr. Arvind Chopra, the lead author and Director at the Centre for Rheumatic Diseases, Pune, emphasized that the study provides crucial evidence on the extract's safety and tolerability for prolonged use.
Market Expansion and Scientific Validation
These positive safety findings arrive as the global Ashwagandha market experiences robust growth. Experts project the Indian Ashwagandha supplements market to reach ₹1,421 crore ($148 million) by 2033, up from an estimated ₹657 crore ($68.4 million) in 2025. Globally, the market is expected to expand from approximately ₹7,296 crore ($760 million) in 2025 to ₹11,328 crore ($1.18 billion) by 2030.
Vaidya Rajesh Kotecha, Secretary of the Ministry of Ayush, highlighted the importance of rigorous clinical research in strengthening the scientific evidence base for Ayurvedic preparations and supporting their responsible use.
Trial Context and Limitations
The study was conducted against the backdrop of the COVID-19 vaccination program, with researchers also investigating any potential impact of Ashwagandha on the immune response generated by the Covishield vaccine. While the Ashwagandha group showed no additional immune benefit, neutralizing antibody levels remained high in both the treatment and placebo groups, with no statistically significant difference.
Adverse events reported were mostly mild to moderate, primarily affecting the digestive system, and occurred at similar rates in both groups. Crucially, no serious adverse events were deemed related to the Ashwagandha treatment.
It is important to note that the study's findings apply specifically to the standardized aqueous root extract and dose tested in apparently healthy adults aged 18 to 70 years. The research does not extend to all Ashwagandha products or establish efficacy for conditions such as stress, anxiety, or sleep problems, which would require further targeted studies.